Manifold hub for patient fluid administration

ABSTRACT

The present invention concerns a housing for supporting the proximal inlet ports of at least two isolated lumens, for use in a patient fluid administration system, wherein each of the lumens further comprises a distal outlet for connecting to at least one patient fluid administration member, and wherein the housing further comprises an integral unit, wherein the unit comprises a distal frame layer, a female connector layer, for connecting to at least one of the fluid peripheral elements and at least one intermediate gasket layer for providing sealing between each of the isolated lumens.

CROSS REFERENCE TO RELATED APPLICATION

This application is a continuation of U.S. patent application Ser. No.11/132,642, filed May 19, 2005, which is a continuation-in-part ofInternational Application No. PCT/IL2003/000983, filed Nov. 19, 2003,the content of which is expressly incorporated herein by referencethereto, which claims priority from Israeli Patent Application No.152950 filed Nov. 19, 2002.

FIELD OF THE INVENTION

The present invention generally relates to a manifold hub for use in afluid administration system. In particular, the present inventionrelates to a manifold hub which is characterized by a plurality ofmutually distinct flow channels that comprise a plurality of isolatedlumens. More particularly, the present invention relates to a manifoldhub in the form of a housing comprising a plurality of isolated lumens.

BACKGROUND OF THE INVENTION

For the sake of clarity, the following terms, which shall be used in thepresent application, are to be defined as follows:

The terms “inlet” and “outlet” as used herein as referring to liquidports, do not come to limit the use of such a port to a directional flowof the fluid, and in some cases (such as dialysis) the direction can bereversed.

The term “fluid peripheral elements”, as used herein, includes any fluidreservoir that is intended to supply fluid to a patient, such as aninfusion bag containing blood plasma or a therapeutic agent; variousdialysis apparatus; pumps and the like. Additionally, this term mayrefer to any element that is intended to cause fluid to flow out fromthe patient such as in case of a dialysis system, that removes andreinserts blood from and into the patient respectively.

The term “patient fluid administration member” refers to any elementwhich is connected on one side (its proximal side) to the manifold hub,and on the other side (its distal side) either directly or indirectly toan entry member, which is inserted to the patient's vascular system, orto any other orifice or vessel of the patient. Examples of “patientfluid administration members” include individual tubes, which may besingle or multi lumen, or a plurality of tubes, singular or multi lumen,that may be attached to each other in a bus type configuration. Thesetubes, in turn, can be connected to, for example, a needle, a catheterwhich is fully or partially inside the patient's vascular system orother vessel, a cannula and the like. The manifold may also be connectedto a multi lumen tube which is within the body of the patient, the tubeforming an extension-less catheter. It should be noted that the term“patient fluid administration member” is not solely intended to denote amember capable of administering fluid into the patient but also to amember capable of removing blood from the patient to the peripheralelement, for example, in dialysis.

The term “fluid administration system” as used herein, refers to asystem for transferring fluid, comprising at least a manifold hub, atleast one fluid peripheral element and a fluid administration member, asdescribed below.

The term “fluid administration external infusion manifold”, as usedherein below, as well as a variety of particular embodiments, shall beall referred to herein in the general term “manifold” or “manifold hub”.A manifold generally comprises a plurality of inlets, having a singleoutlet. A manifold hub, to which the present invention relates, isgenerally a device for connecting a plurality of inlet ports to at leastone external object. In particular, the manifold hub may comprise anidentical number of inlets as outlets, or, alternatively, the number ofinlets may be different than that of outlets. Additionally, forsimplicity's sake, although some embodiments as described herein relateto a plurality of isolated lumens joined by a single port at one end,i.e. a hub, and others, to a plurality of isolated lumens that are notjoined at one end, the term “manifold hub” is used throughout.

The terms “upper” and “lower”, in particular, when referring to theintermediate gasket layers of the present invention, as describedherein, are meant to describe different layers of the housing of thepresent invention, relative to each other, and not to imply that bothlayers need always be present. In other words, when only the upperlayer, or only the lower layer may be present, the layers arenevertheless referred to as “upper” or “lower”, respectively.

The terms “sealing” and “isolated” as used herein, particularly whendescribing the relationship between lumens, refer to preventing at leastfluid communication between lumens or flow channels.

The term “fluid”, as used herein, shall refer to any liquid, solvent,diluent, saline, water, liquefied medicament as well as to any biofluid,human or other, allowed to flow out of or withdrawn from the body of apatient, including blood and blood products, plasma, nutrients andmedicaments.

The term “standard” and the term “conventional” when referring to afemale luer (FL) activated valve (also referred to herein as, “lueractivated connector”) or when referring to a male luer (ML) or MaleLuerlock (MLL), generally relates to any normal, ISO, ANSI and/oruniversal luer activated valve type connection known in the art. Highflow connectors are adapted to provide a flow of fluids in a flux higherthan that allowed by the aforementioned conventional FL. A high flowconnector is thus characterized by having a larger bore, and itsconnecting coupler is larger than a conventional luer activatedconnector. The term ‘connector having a minimal dead space’ is definedas a connector characterized by a small bore, and its connecting coupleris smaller than that of a conventional luer connector. The standard lueractivated connectors as described herein preferably comprise a standardluer lock feature for the standard connector locking system and/or withany other locking feature for the high and low connector locking system.

Fluid administration external infusion manifolds are widely used foradministering therapeutic fluids, into the body of a patient, from aplurality of fluid reservoirs. Currently available manifolds do notprovide simultaneous infusion of a plurality of fluids in a manner suchthat fluids do not mix as they pass through the manifold.

Typically, a manifold, in particular, a manifold connected to a catheterdevice, comprises a single lumen having an outlet port, through which afluid is transferred, to a patient. The single lumen has multiple inletports, each of which can be connected to a separate fluid reservoir, andvalves, such as stopcock valves, for closing and opening the entry offluid to the lumen. However, since all fluids flow through the single,common lumen, and out the same outlet port, when using the manifold, theworking fluid mixes with fluid residue contained within the lumen from aprevious use, which can result in undesirable interaction between thefluids.

This problem is overcome by flushing the lumen with a neutral fluid,such as saline, before administering a second fluid, in order to replacethe dead space to the manifold.

It is evident that this method of cleaning the manifold from excessfluid is undesirable, as unnecessary administration of a “neutral” fluidis required.

Furthermore, prior art administration systems require much handling bythe medical personnel (e.g. nurses), including rinsing, flushing andopening and closing of valves and/or stopcocks in order to remove theresidue fluid. This further increases the risk of undesirabletherapeutic fluid mixing.

Additional requirements of fluid administration systems include primingthe manifold prior to use, wherein the entire manifold housing is primedwith a predetermined solution in order to prepare the manifold for useby ensuring the lumen is free from air bubbles.

In prior art manifolds, individual connectors, such as luer activatedconnectors, are individually situated at each manifold inlet port forsecuring each of the plurality of fluid reservoirs to the ports.

A device for simultaneously administering two or more fluids to apatient, without allowing the fluids to mix, is well known, for use withcatheters. The hub of a multi lumen catheter is connected in itsproximal end to isolated lumen extensions that are connected to fluidreservoirs when fluid is required to be administered to the patient, andmay be disconnected therefrom when not requiring fluid administration.For prior art catheters, the patient must cope with the awkwardnessassociated with tubes exiting the body. For instance, multi lumencatheter hub designs cause irritation when mounting in place and causethe patient discomfort when dressing and undressing. These drawbacks areparticularly undesirable during long term treatments. It would thereforebe beneficial to have a catheter that does not require tubes to exit thepatient's body when not in use.

SUMMARY OF THE INVENTION

The present invention relates to a housing for supporting the proximalinlet ports of at least two isolated lumens, for use in a patient fluidadministration system, wherein each of said lumens further comprises adistal outlet for connecting to at least one patient fluidadministration member, and wherein said housing further comprises anintegral unit, said unit comprising a distal frame layer, a femaleconnector layer, for connecting to at least one of said fluid peripheralelements and at least one intermediate gasket layer for providingsealing between each of said isolated lumens.

More particularly, the present invention provides a specific embodimentof a manifold hub for use in a fluid administration system comprising anintegrated housing providing a plurality of mutually distinct flowchannels through the housing and being composed of at least threecomponents. A first component serving as a connector layer comprises anelongated first member having a plurality of longitudinally spaced firstopenings each associated with a distinct flow channel and a plurality oflongitudinally spaced upward, tubular first projections surrounding andaligned with said first openings and open at their upper and lowerextremities each associated with a distinct flow channel, The firstprojections are formed as one part of a two-part connector. A secondcomponent serving as a distal frame layer comprises an elongated secondmember having a plurality of longitudinally spaced second openings eachassociated with a distinct flow channel and defining a plurality oflongitudinally spaced separate outlets each associated with a distinctflow channel. An intermediate component serving as a gasket layercomprises an elongated third member that is resilient and has aplurality of longitudinally spaced third openings each associated with adistinct flow channel and a plurality of longitudinally spaced upwardannular second projections each associated with a distinct flow channel.Each second projection surrounds a respective third opening. The secondprojections have closures at their upper extremities with normallyclosed slits defined in said closures and are open at their lowerextremities. The first, second and third components are stacked togetherwith the intermediate component between the first and second componentsand integrated together to form the housing with said second projectionsreceived in the first projections with the closures at the upperextremities of the second projections exposed at the upper extremitiesof the first projections, the second openings and the third openingsbeing in fluid communication, the integrated components establishing theplurality of mutually distinct flow channels through the housing, andthe intermediate component serving to seal the mutually distinct flowchannels one from the other. A plurality of valves are mounted in thehousing upstream of the plurality of longitudinally spaced separateoutlets for controlling fluid flow through the plurality of mutuallydistinct flow channels, with each said valve associated with a distinctflow channel. Each said first projection can be connected to a fluidadministration set via a terminal complementary part to said one part ofthe two-part connector such that when the connector is complete, theresilient second projection received in said first projection isdepressed downwardly forcing the normally closed slit defined in theclosure at the upper extremity thereof to open. The separate outlets ofthe second component can be connected to separate lumens each terminatedwith its own element for infusing fluid into a patient.

In another embodiment, the present invention provides a manifold hub foruse in a fluid administration system comprising an integrated rigidhousing providing a plurality of mutually distinct flow channels throughthe housing and being composed of four components. A first componentcomprises a rigid elongated first member having a plurality oflongitudinally spaced first openings each associated with a flow channeland a plurality of longitudinally spaced, upward, tubular firstprojections open at their upper and lower extremities surrounding andaligned with said first openings each said first projection formed asone part of a two-part connector, and each associated with a flowchannel. A second component comprises a rigid elongated second memberhaving a plurality of longitudinally spaced second openings eachassociated with a flow channel, and defining a plurality oflongitudinally spaced separate outlets each associated with a flowchannel, said second component further defining a longitudinallyextending groove laterally offset from the plurality of longitudinallyspaced second openings. A first resilient intermediate componentcomprises an elongated third member having a plurality of longitudinallyspaced third openings each associated with a flow channel and aplurality of longitudinally spaced upward annular second projectionseach associated with a flow channel. Each second projection surrounds arespective third opening, and has a closure at its upper extremity witha normally closed slit defined in said closure and is open at its lowerextremity. A second resilient intermediate component comprises anelongated member having a plurality of longitudinally spaced fourthopenings in the form of normally closed slits, each associated with aflow channel, the fourth openings surrounded by open upstanding tubularthird projections. A plurality of valves are mounted in said housingdownstream of said groove, each associated with a flow channel. Thesecond component defines passageways extending from said groove to saidvalves. The first, second, third and fourth components are stackedtogether in the order of first component, first intermediate component,second intermediate component and second component and integratedtogether to form the rigid housing with said second projections receivedin the first projections with the closures at the upper extremities ofthe second projections exposed at the upper extremities of the firstprojections. The lower open extremities of said annular secondprojections are received in said third projections. The fourth openingsare aligned with the second openings of the second component. Theintegrated components establish the plurality of mutually distinct flowchannels through the housing. The resilient intermediate componentsserve to seal the groove and the mutually distinct flow channels onefrom the other. A plurality of valves are mounted in the housingupstream of the plurality of longitudinally spaced separate outlets forcontrolling fluid flow through the plurality of mutually distinct flowchannels, with each said valve associated with a different distinct flowchannel. Each said first projection can be connected to a fluidadministration set via a terminal complementary part to said one part ofthe two-part connector such that when the connector is complete, theresilient second projection received in said first projection isdepressed downwardly forcing the normally closed slit defined in theclosure at the upper extremity thereof to open. Further, when an annularsecond projection is depressed upon connection of the connector in itsflow channel, the lower extremity of the depressed second projectionmoves downwardly opening the normally closed slit of the fourth openingin said flow channel. Also, the separate outlets of the second componentcan be connected to separate lumens each terminated with its own elementfor infusing fluid into a patient. Alternatively, the separate openingscan be connected to rigid lumens or tubes which terminate at a fittingthat maintains the plurality of distinct flow channels and enablesattachment of the plurality of distinct flow channels to the proximalinput ends of a plurality of lumens terminated at their distal ends withtheir own elements for infusing fluid into a patient.

Preferably, the distal frame layer comprises at least two distal frameports, and wherein said distal frame layer is situated above theproximal inlet ports of the isolated lumens, wherein at least one of thedistal frame ports is aligned with a corresponding proximal inlet portof the isolated lumens.

Preferably, the distal frame layer may further comprise at least onevalve for controlling fluid entry to at least one isolated lumen,wherein said valve may be positioned in at least any one of thefollowing positions:

a. open position, for allowing fluid to enter said lumen;

b. closed position, for preventing fluid from entering said lumen.

According to a first embodiment, the distal frame layer furthercomprises at least one priming port for inserting a priming fluidthereto and a priming groove for carrying said priming fluid to at leastone distal frame port, and further comprise at least one valve, whereinsaid valve may be positioned in at least any one of the followingpositions:

a. priming position, for allowing fluid communication between thepriming port and a corresponding lumen;

b. fluid flow position, for allowing fluid communication between thedistal frame port and a corresponding lumen;

c. flushing position, for allowing fluid communication between thepriming port and the distal frame port;

d. closed position, for preventing fluid communication from taking placewithin said distal frame layer.

According to the first embodiment, the distal frame layer furthercomprises at least one valve, wherein said valve may be positioned in atleast any one of the following positions:

c. open position, for allowing fluid communication between an distalframe port and a corresponding priming groove;

d. closed position, for preventing fluid communication between an distalframe port and a corresponding priming groove.

The female connector layer, according to the first embodiment,preferably comprises at least one priming connector selected from anyone of the group comprising:

a. standard female connector;

b. large bore connector;

c. small bore connector.

The priming connector is optionally a luer activated type connector.

Preferably, the priming connector is situated above the priming port.

According to all embodiments, the female connector layer preferablycomprises at least two female connectors, wherein each connector may beselected from any one of the group comprising:

a. standard female connector;

b. large bore connector;

c. small bore connector.

According to all embodiments, the connector may be a luer activated typeconnector.

According to all embodiments, any one of a large bore and small boremale connector may mate with its corresponding female connector.Additionally, any one of a large bore and small bore cover is adapted tocover its corresponding female connector. In these cases, any one of thelarge and small bore cover and large and small bore male connector issecured to its corresponding by any mechanical means such as a screw.

According to all embodiments, the at least one intermediate gasket layercomprises any one of the group consisting of:

a. lower gasket layer;

b. upper gasket layer;

c. lower and upper gasket layers.

According to a first aspect, the lower gasket layer comprises anelongated flat portion having at least two slots, wherein said slots areopen when in use, for fluid to flow therethrough, and sealed when not inuse, thereby preventing fluid from flowing therethrough.

According to a second aspect, the lower gasket layer further comprisesat least two lower gasket members spaced along the elongated flatportion and protruding upwards therefrom, wherein said lower gasketmembers comprise an O-ring configuration, wherein at least one slot issituated beneath a corresponding lower gasket member, and wherein saidlower gasket member is aligned above the proximal inlet port of acorresponding lumen. The lower gasket layer may further comprise agasket extension depending therefrom, for lodging within the primingport.

According to the second aspect, an outwardly extending flange may besituated at the lower end of the gasket extension, wherein in a forwardfluid flow position, said flange bends in the direction of said fluidflow, for allowing fluid to flow out of the priming port, and wherein ina retrograde fluid flow position, said flange is in contact with theinner wall of said priming port, thereby preventing fluid flow into saidpriming port.

Preferably, according to the second aspect, a rigid stem depends fromthe female connector, and wherein said stem is lodged in the gasketextension for providing rigid support thereto.

According to a third aspect the lower gasket layer comprises a gasketextension depending therefrom, for lodging within the priming port.

According to the third aspect, an outwardly extending flange may besituated at the lower end of the gasket extension, wherein in a forwardfluid flow position, said flange bends in the direction of said fluidflow, for allowing fluid to flow out of the priming port, and wherein ina retrograde fluid flow position, said flange is in contact with theinner wall of said priming port, for preventing fluid flow into saidpriming port.

Preferably, according to the third aspect, a rigid stem depends from thefemale connector, and wherein said stem is lodged in the gasketextension for providing rigid support thereto.

According to a fourth embodiment, the upper gasket layer comprises anelongated flat portion and at least two upper gasket members spacedalong said elongated flat portion and protruding upward therefrom,wherein at least one of the upper gasket members is aligned above aproximal inlet port of a corresponding lumen.

According to the fourth aspect, the upper gasket member furthercomprises a hollow channel portion, having at its upper end, a truncatedconical portion, wherein said upper end further comprises a flat topportion and a slot at said flat top portion for allowing fluid to passthrough when in use, and for preventing fluid from passing through whennot in use.

Preferably, according to the fourth aspect, the upper gasket memberfurther comprises an outer sleeve portion at its lower end, forproviding support to the hollow channel portion.

Preferably, according to the fourth aspect, upon longitudinallycompressing the upper gasket member, the slot opens for fluid to passtherethrough.

According to a fifth aspect, the upper gasket layer further comprises agasket extension depending therefrom for lodging within the primingport.

According to the fifth aspect, an outwardly extending flange may besituated at the lower end of the gasket extension, wherein in a forwardfluid flow position said flange bends in the direction of said fluidflow, for allowing fluid to flow out of the priming port, and wherein ina retrograde fluid flow position, said flange is in contact with theinner wall of said priming port, for preventing fluid from flowingwithin said priming port.

Preferably, according to the fifth aspect, a rigid stem depends from thefemale connector, wherein said stem is lodged in the gasket extensionfor providing rigid support thereto.

According to a sixth aspect, the at least one intermediate gasket layercomprises a lower layer according to any one of the aspects as describedabove, and an upper gasket layer comprising an elongated flat portionand at least two upper gasket members spaced along said elongated flatportion and protruding upward therefrom, wherein at least one of theupper gasket members is positioned above a proximal inlet port of acorresponding lumen.

According to the sixth aspect, the upper gasket member comprises ahollow channel portion, having at its upper end, a truncated conicalportion, wherein said upper end further comprises a flat top portion anda slot at said flat top portion for allowing fluid to pass through.

Preferably, according to the sixth aspect, the upper gasket memberfurther comprises an outer sleeve portion at its lower end, forproviding support to the hollow channel portion.

Preferably, according to the sixth aspect, upon longitudinallycompressing the upper gasket member, the slot opens for fluid to passtherethrough.

According to a seventh aspect, the at least one intermediate gasketlayer comprises a lower layer according to any one of the aspects asdescribed above, and an upper gasket layer comprising an elongated flatportion and at least two upper gasket members spaced along saidelongated flat portion and protruding upward therefrom, wherein at leastone of the upper gasket members is aligned above a proximal inlet portof a corresponding lumen.

According to the seventh aspect, the upper gasket member furthercomprises a hollow channel portion, having at its upper end, a truncatedconical portion, wherein said upper end further comprises a flat topportion and a slot at said flat top portion for allowing fluid to passthrough when in use, and for preventing fluid from passing through whennot in use.

Preferably, according to the seventh aspect, the upper gasket memberfurther comprises an outer sleeve portion at its lower end, forproviding support to the hollow channel portion.

Preferably, according to the seventh aspect, upon longitudinallycompressing the upper gasket member, the slot opens thereby allowingfluid to pass therethrough.

According to all aspects, the distal frame layer may further comprise atleast one integral outlet port with permanently connected lumens.

Preferably, each of the permanently connected lumens comprises an outletport selected from any one of the group comprising:

a. female luer connectors;

b. male luer connectors.

According to all embodiments, the distal outlets may be joined by atleast one single multi lumen port located at the distal outlet of eachisolated lumen.

Preferably, the multi lumen port may be selected from any one of thegroup comprising:

a. a male connector;

b. a female connector.

Optionally, the multi lumen port mates with a corresponding connector byany one of the following:

a. threaded connection;

b. snap connection.

c. snug fit connection

The present invention further relates to a method for manufacturing ahousing for supporting the proximal inlet ports of at least two isolatedlumens, for use in a patient fluid administration system, wherein eachof said lumens further comprises a distal outlet for connecting to atleast one patient fluid administration member, and wherein said housingfurther comprises an integral unit, said method comprising:

a. providing a distal frame layer;

b. providing a female connector layer, for connecting to at least one ofsaid fluid peripheral elements;

c. providing at least one intermediate gasket layer for providingsealing between each of said isolated lumens;

d. sealingly joining said distal frame layer with said female connectorlayer, wherein said at least one intermediate gasket layer is situatedin between said distal frame layer and said female connector layer.

Preferably, the method further relates to providing an at least oneintermediate gasket layer may comprise any one of the group comprising:

a. upper gasket layer;

b. lower gasket layer;

c. lower and upper gasket layer.

BRIEF DESCRIPTION OF THE FIGURES

The present invention will be further explained in detail by theFigures. These figures are solely intend to illustrate several preferredembodiments of the present invention, and in no manner intend to limitthe scope of this invention to the illustrated figures. It should beappreciated that a large variety of changes could be performed to theillustrated embodiments by those who skill in the art without departingfrom the scope of this invention.

FIG. 1 illustrates a front view of one embodiment of a manifold hubaccording to the present invention.

FIGS. 1A, 1B, 1C, 1D, 1E and 1F illustrate several embodiments of amulti lumen port and a matching multi lumen plug, according to thepresent invention.

FIGS. 1G and 1H illustrate embodiments of a converging adapter accordingto the present invention.

FIG. 2 illustrates an embodiment of manifold hub according to thepresent invention, being accessed by peripheral devices.

FIG. 2A illustrates a lateral cross sectional view of a multi lumen tubethat is connected to the manifold of FIG. 2.

FIG. 3A illustrates an embodiment of a manifold having two isolatedlumens, as being accessed by peripheral elements, and having aconverging adapter connected to its multi lumen port.

FIG. 3B illustrates another embodiment of manifold having two isolatedlumens, used with a catheter.

FIG. 3C illustrates a lateral cross sectional view of the catheter ofFIG. 3B.

FIG. 4 illustrates in an exploded view the components or parts (layers)from which a multi layer manifold housing, having four layers, may beassembled.

FIG. 5 illustrates the inner construction and shape of one embodiment ofa female port of the manifold, as it is seen in an initial position(i.e. before being accessed by a matching male connector).

FIG. 5A illustrates the inner construction and shape of the embodimentof FIG. 5, after being accessed by a matching male connector.

FIGS. 6A, 6B, 6C, 6D, 6E and 6F illustrate six different embodiments ofmulti layer construction of female ports of the manifold, wherein FIGS.6A-6D show three different operational states and FIGS. 6E and 6F showtwo operating states.

FIGS. 7A, 7D, 7E, and 7F, illustrates four different embodiments ofmulti layer construction of double tubing connectors corresponding tothe four embodiments of FIGS. 6A, 6B, 6C and 6D.

FIG. 7B illustrates one embodiment of a double tubing male connectoraccording to the present invention.

FIG. 7C illustrate the double tubing connector of FIG. 7A, accessed bythe male connector of FIG. 7B.

FIG. 7G illustrates one embodiment of a cover for double tubing femaleconnector according to the present invention.

FIG. 7H illustrate the double tubing connector of FIG. 7A, covered bythe cover illustrated in FIG. 7G.

FIG. 7I illustrates one embodiment of a double tubing infusion maleconnector according to the present invention.

FIG. 7J illustrate the double tubing connector of FIG. 7A, accessed bythe infusion male connector of FIG. 7I.

FIGS. 8A to 8F illustrate different embodiments and views of extensionmembers according to the present invention.

FIG. 9 illustrates several embodiments of systems using a manifoldaccording to the present invention.

FIGS. 10, 10A and 10B illustrate an alternative embodiment of theassembled (FIG. 10) and exploded (FIG. 10A) views of the manifold hub ofthe present invention, showing the priming ports and groove (FIG. 10B).

FIGS. 11, 11A, 11B, 11C, 11D, and 11E illustrate other alternativeembodiments comprising the priming features of the manifold hub of thepresent invention.

FIG. 12A shows a longitudinal cross sectional view of the proximal endof one lumen of the priming manifold of the present invention, with thestopcock valve for the female connector in the priming position. FIG.12B illustrates a stopcock valve of the priming manifold of the presentinvention in an exploded perspective view, in the priming position.

FIGS. 12A′ and 12B″ illustrate the view of FIGS. 12A and 12B, whereinonly the upper gasket layer is present.

FIGS. 13A and 13A′ illustrate the views of FIGS. 12A and 12B, with thestopcock valve for the female connector in the fluid flow position.

FIGS. 13B and 13B′ illustrate the views of FIGS. 12A and 12B, with thestopcock valve for the female connector in the closed position.

FIGS. 13C and 13C′ illustrate the views of FIGS. 12A and 12B, with thestopcock valve for the female connector in the flushing position.

FIGS. 13D and 13D′ illustrate the views of FIGS. 12A and 12B, with thestopcock valve for the female priming connector in the open position.

FIGS. 13E and 13E′ illustrate the views of FIGS. 13D and 13D′, with thestopcock valve for the female priming connector in the closed position.

FIGS. 14A, 14B, 14C, 14D and 14E illustrate a further embodiment of thepriming manifold of the present invention, wherein the priming connectoris situated along the priming groove respectively, FIG. 14A showing anassembled side view, FIG. 14B an exploded view, 14C a top view of thedistal frame layer or component showing the priming groove, 14D a topview of the connector or proximal frame layer or component showing thepriming input, and 14E a vertical mid-sectional view showing the primingconnector.

FIG. 15 illustrates an embodiment of the priming connector of thepresent invention, wherein the pressure of the priming fluid as it isinserted to the priming connector causes the fluid to flow along thepriming groove, and thereby enter the priming ports.

FIGS. 16, 16A and 16B illustrate a further embodiment of the primingmanifold of the present invention, wherein the female connector isnon-luer activated, and the gasket layer does not comprises gasketmembers.

FIGS. 17A, 17B, 17C and 17D illustrate a further embodiment of thepriming manifold of the present invention, similar to that of FIGS. 14A,14B, 14C and 14D, but without valves.

DETAILED DESCRIPTION OF THE INVENTION

The present invention relates to a manifold useful for simultaneousadministration of fluids via a plurality of isolated lumens or flowchannels, whose distal outlets are maintained separate or joinedtogether by a single port, wherein the proximal inlet ports are viaconnectors that are supported by an integral housing unit, whichcomprises an upper layer, a lower layer and at least one intermediategasket layer for providing a sealing between each isolated flow channelor lumen.

FIG. 1, illustrates a front view of one embodiment of a manifold (100)according to the present invention. This manifold (100) is especiallyuseful for simultaneous administration or draining of fluids via aplurality of isolated flow channels or lumens (101)-(105). The manifoldhas a distal end (A) through which the manifold is meant to communicatewith a patient's body, and a proximal portion (B), through which themanifold is meant to communicate with a plurality of peripheralelements. The isolated lumens (101)-(105), are joined together by amulti lumen port (120) at the distal end (A) of the manifold, such thatmixing of fluids is not possible at any portion of the manifold. Thus,fluid may be administered from a plurality of peripheral elements to abody of a patient through a multi lumen connection. This connection,through which all the lumens continue distinctly, is comprised of twomulti lumen connectors, namely, the multi lumen port (120) that is anintegral part of the manifold, and a multi lumen plug ((221) of FIG. 2),that is the proximal part of the interface with the patient.

The manifold is preferably comprised of a polymeric body, wherein itsproximal portion (B) contains an array of female luer connectors(106)-(110), preferably assembled in a multilayer structure, as willfurther be detailed respective to several different embodimentsillustrated herein below.

The isolated lumens may be arranged in a concentric conicalconfiguration, or along an essentially flat plane or in any otherdesired configuration. The support structure may be formed as a frame oras a block, for housing the isolated lumens and establishing themutually distinct flow channels.

FIG. 1A illustrates one preferred embodiment of a multi-lumen connectionaccording to the present invention. The multi-lumen connection iscomprised of the multi-lumen port (120), located at the distal portion(139) of a manifold of the invention, and of the multi lumen plug (221)of an external or internal multi lumen tube (219). The multi-lumen port(120) comprises the lower ends (142)-(147) of six isolated lumens of themanifold (100), and optionally has a connective thread (139 a) matchinga corresponding thread existing in the multi lumen plug (221). The multilumen plug (221) comprises the protruding upper ends (142 a)-(147 a) ofsix distinct lumens for connecting to the lower ends of isolated lumens(142)-(147). The multi lumen connection further comprises connectiondirective protrusion (148) and recess (149) for aiding and alignment ofthe connection.

The multi lumen connection enables each of the protruding lumen ends(142 a)-(147 a) to separately communicate with corresponding lumen ends(142)-(147). Thus, a continuity of separate fluid flow lumens ismaintained, from each of the peripheral elements through the distal endof the manifold and to the patient.

FIG. 1B illustrates another embodiment of the multi lumen co connection,differing from that of FIG. 1A in that the multi lumen port (120) of thedistal end (139) of the manifold of FIG. 1B comprises protruding lumenends (142 c)-(147 c), while the multi lumen plug (221) hasnon-protruding lumens (142 d)-(147 d), for receiving the protrudinglumen ends (142 c)-(147 c) of the multi lumen port (120).

FIGS. 1C and 1D illustrate further embodiments of the multi lumenconnection, differing from that of FIGS. 1A and 1B, respectively, inthat the connection is made by a snap-on connection, instead of by athreaded connection.

Alternatively, FIGS. 1A, 1B, 1C and 1D may be connected together by apress-fit connection (not shown in the figures.

FIGS. 1E and 1F illustrate further embodiments of the multi lumenconnection differing from that of FIGS. 1A and 1B, 1C and 1D,respectively, in that there are multiple tubes or lumens in FIGS. 1E and1F, aligned in a straight array. In FIGS. 1E and 1F, the details of thesnap-on connection can be more clearly observed. The connection issecured by means of two protrusions (161), (162) adapted to snap overthe matching recess (163) located at the end of a guiding slope (164).Pressing the opposite ends (161 a), (161 b) of the protrusions (161),(162) permits easy disconnection, when required.

It should be appreciated that the number of lumens in the multi lumenconnection, their sizes and respective positioning, as well as theconnection methods, are not restricted to those illustrated in thisdetailed description, thus may be changed or varied without departingfrom the scope of the present invention.

FIG. 1G illustrates the multi lumen connection of FIG. 1A with its multilumen port (120) accessed by a converging adapter (170). According toone embodiment, the converging adapter (170) has a multi lumen end (170a) and a single lumen end (170 b), wherein the lumens of the multi lumenend (170 a) communicate with the lumen of its single lumen end (170 b).The multi lumen end (170 a) connects to the multi lumen port (120) ofthe manifold, and the single lumen end (170 b) faces the interface plugof an entry member (not illustrated). This arrangement allows for aconnection between the manifold and a single lumen entry member, withthe mixing of fluids taking place only in very close proximity to theentrance to the patient's vascular system.

According to another embodiment, the converging adapter (170) is singlelumen on both of its ends.

According to both embodiments the flange (171 c) of the convergingadapter (170), together with its single lumen end (170 b) could bedesigned either as a standard connector, e.g. luer type, or as any othertype of connector. According to another embodiment, the convergingadapter (170) is multi lumen on both of its ends, as illustrated in FIG.1H by multi lumen tip (171 b).

The flange (171 c) of the converging adapter (170) together with itsmulti lumen tip (171 b) (FIG. 1H), could be either a standard connector,e.g. luer type, or a different type connector. According to thisembodiment the mixing of fluids can occur only outside the multi lumentip (171 b).

FIG. 2 illustrates a manifold (200), connected at its proximal portion(B) to a plurality of peripheral elements, such as a syringe (214),(218), double tubing (215), (216) of a dialysis machine, and otherequipment tubing (213) (217), through an array of female connectors.Each peripheral element is connected to one of the array of femaleconnectors by a corresponding male connectors (207)-(211).

It should be noted that the manifold, according to the presentinvention, is shown in this detailed description with luer typeconnectors only as an example. Any type of connective methods or acombination thereof, in particular, any needle-less entry connectorcould be used as well, without departing from the scope of thisinvention.

The manifold (200) communicates with a body of a patient through a multilumen tubing (219), (i.e. the patient fluid administration member),which is connected at one end to the manifold (200) by means of theconnector (221), and connected at its other end to a body invasiveinfusing device (not illustrated) such as a catheter or a needle, bymeans of a standard male or any other type connector (222), therebyallowing for coupling any desirable device having a matching (standardor other type) connector.

The manifold (200) differs from that of FIG. 1, in that the number ofthe lumens is six (instead of five) and in that each of the lumens(225)-(230) is provided with a valve (or, stopcock) (223), enabling auser to control the flow of the fluids through the lumens. The number oflumens and valves that are provided can be independently determined fromthe specific requirements and design considerations, and may vary fromone embodiment to another without departing from the scope of thepresent invention. As an example, the number of lumens in a manifold isbetween 2 and 8, and could be arranged respect to one another in anyconvenient two or three dimensional array. For example, a manifoldhaving six isolated lumens could be manufactured either as a twodimensional array, i.e. with the six lumens angularly spaced from oneanother in a single plane (as illustrated in FIG. 2), or as a threedimensional array, e.g. with the six lumens arranged in two parallelplanes, each containing three angularly spaced lumens.

Furthermore, the manifold (200) differs from that of FIG. 1, in that thehousing is arranged in an arc, rather than in a stepped configuration asin the embodiment of FIG. 1. This, too, is a matter of designconsiderations, and merely serves as illustrative examples of twodifferent embodiments.

FIG. 2A illustrates a lateral cross section of the multi lumen tubing(219). Six cross sectional areas (225 a)-(230 a) could be observed, eachof which corresponds to a separate lumen of the manifold (200) of FIG.2. The different cross sectional areas (225 a)-(230 a) illustrate theway multi lumen tubing can be designed to conform to systemrequirements, wherein for the high flow connector (209), which connectsthe double tubing (215), (216) of the dialysis machine, larger areas(229 a), (230 a) are provided within the multi lumen tubing (219).

FIG. 3A illustrates a double lumen manifold (300), having two femaleluer connectors (301), (302) at its proximal end (B). One connector(302) is connected to a syringe (218) and the other connector (301) isconnected to another peripheral element (not shown) through the tubing(213). The connectors (301), (302) individually communicate with aconverging adapter (170) (according to any of its embodiments referredby the text of FIGS. 1G and 1H) that is connected to the double lumenport (120) by means of the multi lumen end plug (170 a) located at thedistal end (A) of the manifold (300). Two valves (305) and (306) controlthe fluid flow through the lumens (303) and (304), respectively.

FIG. 3B illustrates another embodiment of a double lumen manifold (350).This embodiment differs from that of FIG. 3A in that the lumens do notcontain valves for controlling the flow of the fluids through its lumen,and in that it has a double port at its proximal end (B), adapted toreceive a double tubing connector (209) which is the interface of adialysis machine (not shown). The double tubing connector (209) issecured to the manifold double port by means of a clamp (360 a), (360 b)and protrusion (360 c), (360 d) connection, and further (or optionally)by means of a screw (713). Each of the tubes (215) and (216) that isconnected by the double tubing connector (209) is equipped with a clamp((354) and (355) respectively), which allows the fluid to flow throughthe tubing. Although the clamps are illustrated in a top view, in theiractual position, with respect to the tubes, they are rotated in a 90degree angle respective to the illustration plane. Each tubing (215) and(216) separately communicates with a double lumen catheter (310) that isconnected by means of a double lumen connector (311) located at thedistal end (A) of the manifold (350). It should be appreciated thatwithout departing from the scope of the present invention one mayconstruct the double lumen catheter (310) as an integral extension ofthe double lumen manifold (350), i.e. without a double lumen connector(311), but with an integral non detachable connection between thecatheter (310) and the manifold (350).

FIG. 3C illustrates a lateral cross section (330) of the catheter multilumen tube (310) of FIG. 3B. Two cross sectional areas (331) and (332)can be observed, each of which corresponds to one lumen of the manifold(350) of FIG. 3B.

FIG. 4 illustrates a front exploded view of the support housing at theproximal portion (B) of the manifold (200) of FIG. 2. In this embodimentthe manifold (200) has six lumens that terminate at the manifoldproximal portion (B), four of which are connected to female luer typeconnectors (271)-(274), and the remaining two lumens are connected tohigh flow connectors (275). The housing is assembled using a multi layerconfiguration for establishing a plurality of mutually distinct flowchannels (lumens) consisting of the following layers or components: (a)as a first component the distal frame layer (240) of the manifold body(247), at which the isolated lumens terminate, having a plurality ofdistal frame outlet ports, wherein each distal frame port is positionedabove a corresponding proximal inlet port of an isolated lumen, andoptionally comprising, as shown in this embodiment, a pair of spikes(248) (249), which protrude from the distal frame; (b) a, lowerintermediate gasket layer or component (250) comprising an elongatedflat portion (257) and a plurality of lower gasket members (251)-(256),wherein each distal frame port is positioned above a correspondingproximal inlet port of each lumen, respectively. Optionally, aperturesare located along the flat portion (257), correspond to the positions ofthe spikes, in order to allow for passage of the spikes through theapertures when positioning the lower gasket layer (250) on the surfaceof the proximal frame (247); (c) an upper intermediate gasket layer orcomponent (260) and a plurality of upper gasket members (261), (262),(263), (264), (265 a), (265 a) protruding from above the flat portion(266), for positioning above proximal inlet port of each lumen,respectively; (d) female luer connector layer or component (270)comprising four female luer type connectors (271), (272), (273), (274)and one double, high flow connector (275). The connectors are hollow,and thus adapted to receive of the upper gasket members from the uppergasket layer (260). After assembling the four layers together, themanifold becomes one integral housing unit, enabling, at its proximalportion four luer type connections and one double tubing high flowconnection.

The gasket layers and gasket members may comprise any flexible orresilient material, such as silicone rubber, thermoplastic rubbers, e.g.SEBS, and polyurethanes, for providing fluid communication as well asfluid sealing as described hereinbelow. Nevertheless, any materialhaving equivalent properties are acceptable.

The distal frame layer as well as the female connector layer may bemanufactured of any hard or relatively hard resilient plastic, such aspolycarbonate polysulfone, ABS, polyurethane, modified acryliccopolymer, e.g. cyrolites. Nevertheless, any material having equivalentproperties are acceptable.

Optionally, antiseptic solution and/or an anti-trombolitic agent or anyadmixture thereof is inserted between at least one set of upper andlower gasket members.

FIG. 5 illustrates an enlarged view of a specific example of a multilayer configuration, wherein the distal frame layer (240) of a manifold(not shown) and the upper gasket layer (260) with upper gasket member(261) are shown. The female luer connector layer is not shown. Thisembodiment corresponds to the embodiment illustrated in FIG. 6C, i.e.having only the upper gasket layer, thus having three layers in total.The upper gasket member (261) comprises a hollow channel portion (260 a)and a shoulder-like outer sleeve portion (260 b) protruding from theflat portion (266) of the gasket layer (260). A pair of spikes (248)(249) pass through the outer sleeve portion (260 b). These spikes (248),(249) are an integral part of, and protrude from the distal frame layer(240). The free ends of the spikes (248), (249) are situated inside thetruncated conical portion (260 c) of the gasket member (261). The flattop portion (260 d) at the upper end of the truncated conical portion(260 c) seals the gasket member (261) when not being accessed by a maleconnector, and allows fluid to flow through slot or normally closed slit(260 e) when a male connector is connected to the gasket member (261).The sides of the slot (260 e) sealingly tighten together whenever thegasket member (261) is not accessed by a male connector, therebyallowing the outer surface to be easily swabbed. The interaction betweenthe spikes and the gasket, which open the slot upon connection of a maleconnector plug is illustrated in FIG. 5A.

FIG. 5A illustrates the interaction between the spikes (248), (249) andthe gasket member (261), by which the slot opens upon connection of amale connector, in particular, showing the shape of the gasket member(261), upon exertion of a downwardly directed pressure on the flat topportion (60 d). Such pressure is exerted when a male connector isconnected to the gasket member (261). When the flat top portion (260 d)is pressed downwards, the outer sleeve portion (260 b) folds inaccordion-like shape, and the conical portion (260 c) is stretchedoutwardly by means of the spikes (248), (249) which penetrate thenarrower part of the conical portion (260 c), near its top (260 d). Thismaneuver separates the sides of the slot (260 e), thus enabling fluidcommunication between the male and female connectors.

The interaction between the spikes and the gasket is further detailed inFIG. 6C, as described hereinbelow. Similar interactions are alsodetailed in FIGS. 6A and 6D, and concern other embodiments of the gasketmembers.

FIG. 6A illustrates three cross sectional views corresponding to threemain states, initial (1), middle (2) and final (3) positions, of theupper gasket member (600 a) during a interaction between a male andfemale luer type connectors (601), (600). The support housing iscomprised of the same four layers illustrated in the embodiment of FIG.4, mutatis mutandis: (a) the distal frame layer (240) of the manifoldbody, (b) a first/lower gasket layer (250); (c) a second/upper gasketlayer (260); and (d) a female lure connector layer (270). The maleconnector (601) is comprised of a rotating flange (631) having a maleluer cone (602). In an initial position (1) entry to the proximal inletport of the lumen (not shown) is blocked by the sealing of both theupper gasket member (600 a), the lower gasket member (600 b). Theconical portion (600 c) of the upper gasket member (600 a) minimallyoverlaps the spikes (611) (612), such that in the initial position (1),no stretching forces act to open the slot (not shown in this figure) atthe flat top end (610) of the conical portion (600 c). Furthermore, inthe initial position (1) the flat top portion is situated level with theupper edge (610 a) of the neck portion (613). Thus, the flat top portion(610) is pressed inwards, due to the inwardly exerted pressure from theneck walls on the upper end of the upper gasket (600 a) and the flat topend (610), thereby sealing the slot.

In a middle position (2), the luer cone (602) of the male connector(601) is partially inserted to the female connector (600), thus exertingpressure over the flat top portion (610)) of the upper gasket member(600 a), and thereby forcing the upper gasket member (600 a) to slidedownwards inside the housing. Simultaneously, the conical portion (600c) further overlaps the spikes (611), (612), which, outwardly stretchesthe conical portion (600 c), and in turn stretches the flat top portion(610). As a result, the slot (614) located in the flat top portion (610)is stretched and slightly opens.

In a final position (3), the male connector (601) is fully threaded overthe female connector (600), and its luer cone (602) is fully inserted tothe female connector (600). It can be observed how the conical portionof the upper gasket member (600 a) fully overlaps the spikes (611),(612), thereby fully stretching the flat top portion (610), which causesthe slot (614) to open fully. The outer sleeve portion (610 b), as wellas the inner portion (610 c) of the upper gasket (600 a), are bothcompressed in an accordion like manner as shown in the figures. Theouter sleeve portion (610 b) and the inner portion (610 c), exert anupwardly directed force, which causes the flat top portion (610) topress tightly against the bottom (602 a) of the luer cone (602), therebypreventing leakage of fluids between the luer cone (602) and the uppergasket member (600 a). Simultaneous with the process described above,the upper part of the cannula like member (621), situated at the lowerpart of the inner portion (610 b) of the upper gasket member (600 a),overlaps the upper edge (617) of the lower gasket member (600 b), whilethe lower part (also referred to herein as the “tip”) of the cannulalike member (621) pushes the sealing surface (616) of the lower gasketdownwards to an open position. The cannula-like member (621)additionally comprises an outer and/or inner non-elastic reinforcementuseful for an easy and efficient penetration of the tip into the slot.

FIG. 6B illustrates another embodiment of three cross sectional viewscorresponding to three main states, initial (1), middle (2) and final(3) positions of the upper gasket member (6000 a) during an interactionbetween male and female luer type connectors (601), (600), similar tothose illustrated in FIG. 6A, mutatis mutandis. This embodiment defersfrom that of FIG. 6A in that in FIG. 6B, there are no spikes protrudingfrom the distal frame layer (240) of the manifold body, nor is there aconical portion at the upper part of the upper gasket member (6000 a).When the male cone (6002 a) exerts a downward pressure on the flat topportion (6100 a), the upper part of the channel portion of the uppergasket (6000 a) is forced outwards, thereby widening the opening of theslot (6140 a).

FIG. 6C illustrates another embodiment of three cross sectional viewscorresponding to three main states, initial (1), middle (2) and final(3) positions of the upper gasket member (6000 b) during an interactionbetween male and female luer type connectors (601), (600), similar tothose illustrated in FIG. 6A, mutatis mutandis. This embodiment defersfrom that of FIG. 6A in that FIG. 6C lacks the first gasket layer. Thus,in the final position (3), the lower part of the channel portion of thegasket (6000 b) adheres directly to the inclined lip (625) of thecorresponding distal frame layer port (2400) thereby sealing the port(2400) from leakage. Furthermore, the widened channel portion of thegasket (6000 b), when compressed in the final position (3) is thickened,thereby further preventing leakage.

FIG. 6D illustrates three cross sectional views corresponding to threemain states, initial (1), middle (2) and final (3) positions of theupper gasket member (6000 c) during an interaction between male andfemale luer type connectors (601), (600), similar to those illustratedin FIG. 6A, mutatis mutandis. This embodiment defers from that of FIG.6A in that FIG. 6D lacks the first gasket layer, and further defers fromthe embodiment of FIG. 6A in that the single gasket layer of FIG. 6Clacks the outer sleeve portion through which pass the spikes in FIG. 6A.Accordingly, the spikes (6110), (6120) in this embodiment pass throughapertures (662), (663) in the flat layer (661) of this gasket member(6000 c). In the final position (3), the lower part (665) of the channelportion of the gasket member (6000 c) is positioned along the inclinedlip (664) of the distal frame layer (240).

FIG. 6E illustrates two cross sectional views corresponding to two mainstates, initial (1) and final (3) positions of the upper gasket member(6000 d) during an interaction between male and female luer typeconnectors (601), (600), similar to those illustrated in FIG. 6A ininitial position (1) and final position (3), mutatis mutandis. Thisembodiment differs from that of FIG. 6A in that FIG. 6E does not havespikes protruding from the distal frame layer (240) of the manifoldbody. FIG. 6E further differs in that the channel portion of the uppergasket member (6000 d) does not have folds for compressing in anaccordion-like manner, and, as such, only the outer sleeve portion (6100b) of the upper gasket member (6000 d) is compressed. FIG. 6E furtherdiffers from FIG. 6A in that the lower edge of the cannula-like member(621) is square for fitting into the step (672) that exists at the portof the distal frame layer (240), as shown in the final position (3).

FIG. 6F illustrates two cross sectional views corresponding to two mainstates, initial (1) and final (3) positions of the upper gasket member(6000 d) during an interaction between male and female luer typeconnectors (601), (600), similar to those illustrated in FIG. 6E ininitial position (1) and final position (3), mutatis mutandis. Thisembodiment defers from that of FIG. 6E in that the housing in FIG. 6Fdoes not have a first gasket layer.

In all of the above embodiments, when a male connector is removed from aport, the gaskets retract to their initial position and re-seals thefemale ports until another connection of a male connector is made.

FIG. 7A illustrates a cross sectional view of a double port of themanifold of the present invention, adapted for receiving a correspondingdouble tubing high flow plug. The layers of the housing of the doubleport may be similar to those illustrated in FIGS. 6A to 6F, mutatismutandis except the double port has a larger diameter bore, useful forallowing greater fluid flow rates. The double port differs, however,from the embodiments of FIGS. 6A to 6F in that the distal frame layer ofthe manifold is adapted for the connection of a double tubing plug, andfor securing the plug to the manifold by means of a clamp and/or ascrew. An elevated bridge (710) is provided between each connector ofthe double connector, having an aperture (711) for receiving a screw.FIG. 7B illustrates the double male connector (209) with a screw (713),and FIG. 7C illustrates the double male connector (209) connected to thefemale connector and secured by the screw that is fastened in theaperture (711). Alternatively, although not shown in the figures, anysimilar method of connecting the male to the female connector may beutilized.

FIGS. 7A, 7D, 7E and 7F, correspond to the structures of the proximaland lower gasket members of FIGS. 6A, 6B, 6C and 6D, respectively,showing the gasket members in an initial position.

FIGS. 7G and 7H illustrate a cover (785) for the double female connectorthat can be secured to the double connector when not in use, in order toprotect the double connector from hazards and contamination.

FIGS. 7I and 7J illustrate a cover (786) similar to that shown in FIGS.7G and 7H, having pins (798) for piercing through the slots (788)located at the flat top portion (790) of the upper gasket member (792),sealing the connectors when not in use. When necessary, access to thefemale double connectors without pushing the upper gasket member (792)downwards in order to fully open the slots, is possible through the pins(798). This type of access is necessary for some kinds of patienttreatments (e.g. for dripping purposes).

FIG. 8A illustrates a manifold extension member (800). The extensionmember is comprised of a multi lumen connector (801) corresponding tothe multi lumen port of a manifold (810), and a multi lumen tube (802)which ends with a multi lumen tip (803) and a connector flange (804)together being an outlet connector (805), for connecting to any deviceor equipment having a corresponding connector.

FIG. 8B illustrates two cross sectional views (802 a) and (802 b) of themulti lumen tube (802) of FIG. 8A, taken in along E-E and F-Frespectively.

FIG. 8C illustrates an enlarged view of outlet connector (805) of FIG.8A.

FIG. 8D illustrates a front view of the tip (803) of the multi lumentube of FIG. 8A.

FIG. 8E illustrates another embodiment of an outlet connector (815)which differs from the outlet connector (805) of FIG. 8A, in that theoutlet of FIG. 8E is the outlet for a plurality of isolated single lumentubes (812 a)-(812 e), and in that the outlet of FIG. 8E ends in asingle lumen cone (813) similar to that of (170 b), in the convergingadapter of FIG. 1G.

FIG. 8F illustrates the back terminals (812 f)-(812 j) of the outletconnector (815), which allows for a separate connection of the end eachof the tubes (812 a)-(812 e) to the outlet connector. The outletconnector (815), the plurality of tubes (812 a)-(812 e), and anappropriate multi lumen plug at the opposite end of the tubes matchingthe multi lumen port of a corresponding manifold (see for example FIG.1F), is another embodiment of a manifold extension member.

FIG. 9 illustrates examples of patient administration systems utilizingthe manifold of the present invention, in three differentconfigurations. The manifold may be connected to peripheral elements anddevices such as Hemodialysis-Hemofiltration machine (10); GravitationalIV (11); Multi IV-Pump (12) Syringe-Pump (13) and Volumetric andPeristaltic Pump (18). A patient invasive member, such as Manifold/HubCatheter version (14), could be either integral to the manifold (9) orconnected to its multi lumen port via an appropriate connector.Alternatively, a single lumen Catheter (15) may be connected to themulti lumen port through a manifold extension member (16), or through aconverging adapter (17). For purpose of clarity cross sectional views(14 a), (15 a), (16 a) of (14), (15) and (16) respectively, are shown.

FIGS. 10 to 15 illustrate additional embodiments of the presentinvention, comprising essentially all of the features of all of theprevious embodiments, mutatis mutandis, with the differences describedin detail herein below. As mentioned above, one requirement of fluidadministration systems includes priming the manifold lumens by insertinga desired fluid to the manifold. The embodiments shown in FIGS. 10 to 15describe preferred embodiments of the present invention, wherein theproximal housing unit further comprises features that allow priming themanifold lumens.

FIG. 10 shows the front assembled view of one embodiment of the primingmanifold (1000) of the present invention. The manifold (1000) comprisesfour isolated lumens (1016), (1026), (1036) and (1046) and a housing(1001) having five female luer connectors (1010), (1020), (1030),(1040), (1050), of which four connectors (1010), (1020), (1030), (1040)are respectively situated at the proximal inlet port of each isolatedlumen. The housing (1001) further comprises five valves (or, stopcocks)(1015), (1025), (1035), (1045), (1055), corresponding to each connector.The valves (1015), (1025), (1035), (1045), (1055), are shown in fourdifferent positions, wherein a first valve (1015) is in the primingposition, a second valve (1025) is in the fluid flow position, a thirdvalve (1035) is in the closed position and a fourth valve (1045) is inthe flushing position. The priming connector (1050), shown in the fluidflow position, is not in communication with a lumen of the manifold(1000).

The manifold housing (1001) of FIG. 10 is shown in FIG. 10A in anexploded view, and comprises essentially all of the features shown inFIG. 4, mutatis mutandis, with the following differences. In FIG. 10Athe distal frame layer (1400) comprises five valves, each of which issituated below an distal frame port (1410), (1420), (1430), (1440),(1450) of the distal frame layer (1400), as seen in FIG. 10B, whichshows a top plan view of the distal frame layer (1400). Priming ports(1451), (1452), (1453), (1454), (1455) are shown in fluid communicationwith one another via priming groove (1450′), as will be described hereinbelow. According to some embodiments, the lower gasket layer (1300) ofFIG. 10B comprises gasket extensions (1311) (shown in FIG. 12A) thatdepend downward from the lower gasket layer (1300), for inserting intoeach priming port, thereby enabling one-directional flow of the primingfluid, as will be described herein below. The upper gasket layer (1200)comprises an aperture (1371) (shown in FIG. 12A) along the flat portionof the layer (1200), for inserting a rigid stem (1111) that dependsdownward from the female luer connector, thereto, as will be describedherein below.

FIGS. 11, 11A and 11B illustrate the front view of another embodiment ofthe manifold, and comprise essentially all of the features shown inFIGS. 10, 10A and 10B, with the following differences. In the embodimentshown in FIGS. 11, 11A and 11B the manifold housing (1002) essentiallycomprises a linear shape. FIGS. 11C, 11D and 11E show alternativearrangements of the linear housing, but may be adapted to any housingconfiguration. FIG. 11C shows the distal frame layer (1000′) comprisingintegral outlet ports (50) with permanently connected lumens (51). FIG.11D shows the outlet ports (52) comprising female luer connectors. FIG.11E shows the outlet ports (53) of FIG. 11D, comprising male luerconnectors.

FIG. 12A shows a longitudinal cross sectional side view of an assembledluer connector (1010), cut along the central axis of the connector(1010) in a plane orthogonal to the plane shown in the figure. FIG. 12Bshows the valve (1015) with the positioning member (1015 a) unassembled.The valve (1015) shown in FIGS. 12A and 12B is in the priming position,whereby the priming port (1451) is in fluid communication with the lumen(1016) due to the alignment of the transfer conduit (1015′) of the valve(1015) within the distal frame layer (1400). One-directional flow of thepriming fluid is achieved via a check valve arrangement, wherein thegasket extension (1311) that depends downward from the lower gasketlayer (1300), and the rigid stem (1111) that depends downward from thefemale connector layer (1100), and is inserted to the gasket extension(1311) for support. The extension (1311) and stem (1111) are lodged inthe priming port (1451). Flange (1311′) extends outward. When primingfluid flows (shown by arrows (1372)) through the priming port (1451)from the priming groove (1450′), the flange (1311′) bends in thedirection of the flow. The fluid continues to flow through the transferconduit (1015′) and into the lumen (1016), thereby priming the lumen.Fluid flowing through the transfer conduit (1015′) in the retrogradedirection would cause the flange (1311′) to close the priming port(1451), and not allow any fluid to enter therein.

FIG. 12A′ and 12B′ show a cross section of the luer connector (1020) andthe valve (1025) in a similar view as that of FIGS. 12A and 12B, mutatismutandis, with the following differences. One-directional flow of thepriming fluid is achieved via the gasket extension (1312) that dependsdownward from the upper gasket layer (1200), and the rigid stem (1112)that depends downward from the female connector layer (1100), and isinserted to the gasket extension (1312) for support. The extension(1312) and stem (1112) are lodged in the priming port (1452). Flange(1312′) extends outward. When priming fluid flows (shown by arrows(1372)) through the priming port (1452) from the priming groove (1450′),the flange (1311′) bends in the direction of the flow. The fluidcontinues to flow through the transfer conduit (1025′) and into thelumen (1026), thereby priming the lumen. Fluid flowing through thetransfer conduit (1025′) in the retrograde direction would cause theflange (1312′) to close the priming port (1452), and not allow any fluidto enter therein.

FIGS. 13A and 13A′ show a cross section of the luer connector (1020) andthe valve (1025) in a similar view as that of FIGS. 12A and 12B, mutatismutandis, with the following differences. The valve (1025) is in thefluid flow position, which allows fluid communication between the distalframe port (1420) of the distal frame layer (1400) and the lumen (1026).The priming port (1452) is sealed, thereby not allowing priming to takeplace.

FIGS. 13B and 13B′ show a cross section of the luer connector (1030) andthe valve (1035) in a similar view as that of FIGS. 12A and 12B, mutatismutandis, with the following differences. The valve (1035) is in theclosed position, such that no fluid communication within the housing ispossible.

FIGS. 13C and 13C′ show a cross section of the luer connector (1040) andthe valve (1045) in a similar view as that of FIGS. 12A and 12B, mutatismutandis, with the following differences. The valve (1045) is in theflushing position, wherein the priming port (1454) is in fluidcommunication with the distal frame port (1440) of the distal framelayer (1100) via transfer conduit (1045′). Priming fluid is introducedto the housing after use, and remains in place until reuse, when thefluid is removed from the manifold by flowing through the lumen.

FIGS. 13D and 13D′, and FIGS. 13E and 13E′ show a cross section of thepriming connector (1050) and the valve (1055) in a similar view as thatof FIGS. 12A and 12B, mutatis mutandis, with the following differences.The priming valve (1055) is shown in its open and closed positionsrespectively. In the open position (FIGS. 13D and 13D′), the primingfluid is fed into the priming connector (1050) and enters the distalframe port (1450) of the distal frame layer (1100). The priming fluidcontinues to flow within the transfer conduit (1055′), up the primingport (1455) and into the priming groove (1450′). The fluid flows throughthe priming groove (1450′) to the priming ports located along the distalframe layer (1100) in order to prime their respective lumens. In thevalve's (1055) closed position (FIGS. 13E and 13E′), fluid communicationbetween the upper port of the distal frame layer (1100) and the primingport (1455) is not possible.

FIGS. 14A, 14B, 14C, 14D and 14E illustrate another embodiment of amanifold housing, comprising essentially all of the features shown inthe previous embodiments of the priming manifold, in particular, thesame four housing layers or components, mutatis mutandis, with thefollowing differences. In FIGS. 14A, 14B, 14C and 14D the housingcomprises four female luer connectors (2110)-(2140), a double high flowport (2051) having two female non-luer connectors (2050 a), (2050 b) anda priming connector (2050 c).

In the exploded view of the housing shown in FIG. 14B, in the distal(lower) frame layer or component shown in FIG. 14B, and the top planview shown in FIG. 14C, an additional middle priming port (2455 c) issituated along the priming groove (2450′), for directly filling thepriming groove with priming fluid, as will be described herein below.The lower intermediate gasket layer or component (2300) comprises twolarge gasket members (2350 a), (2350 b) for accommodating the high flowconnectors, and an additional gasket (2350 c) is situated along thelower intermediate gasket layer, above the middle priming port (2455 c).The female luer connector layer or component (2100), shown in top planview in FIG. 14D, comprises aperture (2711) for receiving a screw,similar to that shown in FIG. 7A, mutatis mutandis, in order to hold afitting of the types shown in FIG. 7. As shown in FIG. 14A-E, themanifold hub is comprised of a housing composed of four components,namely, a rigid connector component, an upper resilient intermediategasket component, a lower resilient intermediate gasket component and adistal frame layer or component. A plurality of mutually distinct flowchannels are established through the housing and valves are associatedwith the plurality of distinct flow channels. The mechanism of how thegaskets, via the normally closed slits, maintain the flow channels openor closed has been previously described in detail.

FIG. 14E shows a cross section of the luer connector (2050 c) in asimilar view as that of FIG. 12A, mutatis mutandis, with the followingdifferences. The port (2455 c) is situated along the priming groove(2450′). Thus, priming fluid that is inserted to the connector (2050 c)flows directly to the priming groove (2450′). Additionally, in FIG. 14E,a valve is not present for opening and closing the port.

FIG. 15 shows another embodiment of the priming connector (4050) whereinthe distal frame layer does not comprise a valve. Thus, priming fluid isinserted to the connector (4050) and flows from the distal frame port(4450) of the distal frame layer to the priming port (4450′) via thepriming groove (4555).

FIGS. 16, 16A and 16B show an alternative embodiment of the priminghousing of the present invention, similar to that shown in FIGS. 11, 11Aand 11B, mutatis mutandis, wherein the housing is shown with only onegasket layer (5200), and comprising a female connector layer (5100)whose female connectors are not the luer activated type, and is justmeant to be utilized as a priming housing for the manifold.

FIGS. 17A, 17B, 17C and 17D illustrate another embodiment of a manifoldhousing, comprising essentially all of the features shown in theembodiments of FIGS. 14A, 14B, 14C, 14D and 14E, in particular, the samefour housing layers, mutatis mutandis, with the following differences.In FIGS. 17A, 17B, 17C and 17D the distal frame layer does not comprisevalves. FIG. 17B, shows a cross section of the luer connector (3371) ina similar view as that of FIG. 12A, mutatis mutandis, however, in FIG.17B, no valve is shown.

According to all embodiments, the distal frame layer optionally does notcomprise any valves for regulating the fluid flow through theconnectors. Alternatively, some valves may be present for regulatingfluid flow through some connectors. Additionally, it is appreciated thatthe priming connector is not required to be located at any particularlocation along the housing, and that the positions described herein arefor illustrative purposes only.

1. A manifold hub for use in a fluid administration system comprising:A. an integrated housing providing a plurality of mutually distinct flowchannels through the housing and being composed of at least threecomponents; i. a first component comprised of a first member having aplurality of spaced first openings each associated with a distinct flowchannel and a plurality of spaced upward, tubular first projectionssurrounding and aligned with said first openings and open at their upperand lower extremities each associated with a distinct flow channel, saidfirst projections formed as one part of a two-part connector; ii. asecond component comprised of a second member having a plurality ofspaced second openings each associated with a distinct flow channel anddefining a plurality of spaced separate outlets each associated with adistinct flow channel; iii. an intermediate component comprised of athird member being resilient and having a plurality of spaced thirdopenings each associated with a distinct flow channel and a plurality ofspaced upward annular second projections each associated with a distinctflow channel, each second projection surrounding a respective thirdopening, said second projections having closures at their upperextremities with normally closed slits defined in said closures andbeing open at their lower extremities; B. said first, second and thirdcomponents being arranged together with the intermediate componentbetween the first and second components and integrated together to formsaid housing (a) with said second projections received in the firstprojections with the closures at the upper extremities of the secondprojections exposed at the upper extremities of the first projections,(b) the second openings and the third openings being in fluidcommunication, (c) the integrated components establishing the pluralityof mutually distinct flow channels through the housing, and (d) themutually distinct flow channels sealed one from the other; C. wherebyeach said first projection can be connected to a fluid administrationset via a terminal complementary part to said one part of the two-partconnector such that when the connector is complete, the normally closedslit defined in the closure at the upper extremity of the resilientsecond projection is opened; and D. whereby the separate outlets of thesecond component can be connected to separate lumens each terminatedwith its own element for infusing fluid into a patient.
 2. The inventionof claim 1 further including a plurality of valves mounted in thehousing upstream of the plurality of spaced separate outlets forcontrolling fluid flow through the plurality of mutually distinct flowchannels, with each said valve associated with a distinct flow channel.3. The invention of claim 1 wherein the second component includes areservoir and the housing includes a fluid channel for introducing fluidto said reservoir, and a plurality of passageways placing said reservoirin fluid communication with said plurality of separate outlets.
 4. Theinvention of claim 3 wherein check valves are interposed in theplurality of passageways.
 5. The invention of claim 3 wherein controlvalves are mounted in the housing upstream of the separate outlets andin communication with the plurality of passageways for controlling fluidflow in each channel by priming said channel, flushing said channel,shutting off said channel, and enabling flow through said channel. 6.The invention of claim 1 wherein at least one of the mutually distinctflow channels has a higher flow capacity than other flow channels andwherein the first projection associated with the at least one flowchannel is provided with a fitting mounted on said first component forcontrolling flow through said at least one flow channel.
 7. Theinvention of claim 1 wherein a second intermediate component is providedbetween the first intermediate component and the second component, saidsecond intermediate component is resilient and has a plurality of spacedfourth openings aligned with the second openings of the second componentand constitute part of the mutually distinct flow channels.
 8. Theinvention of claim 7 wherein said fourth openings of said secondintermediate component are in the form of normally closed slitssurrounded by open upstanding tubular third projections into which arereceived the lower open extremities of said annular second projections,and wherein the lower extremity of the second projection coacts to openthe normally closed slit of the fourth opening in said flow channel. 9.The invention of claim 7 further including a plurality of valves mountedin the housing upstream of the plurality of spaced separate outlets forcontrolling fluid flow through the plurality of mutually distinct flowchannels, with each said valve associated with a distinct flow channel.10. The invention of claim 7 wherein the second component includes areservoir and the housing includes a fluid channel for introducing fluidto said reservoir, and a plurality of passageways placing said reservoirin fluid communication with said plurality of separate outlets.
 11. Theinvention of claim 10 wherein check valves are interposed in theplurality of passageways.
 12. The invention of claim 10 wherein controlvalves are mounted in the housing upstream of the separate outlets andin communication with the plurality of passageways for controlling fluidflow in each channel by priming said channel, flushing said channel,shutting off said channel, and enabling flow through said channel.
 13. Ahub for use in a fluid administration system comprising: A. a housingproviding at least two mutually distinct flow channels through thehousing and being composed of at least three components; i. a firstcomponent comprised of a first member having at least two separate firstopenings each associated with a distinct flow channel and at least twoof tubular first projections surrounding and aligned with said firstopenings and open at their upper and lower extremities each associatedwith a distinct flow channel, said first projections formed as one partof a two-part connector; ii. a second component comprised of a secondmember having at least two second openings each associated with adistinct flow channel and defining at least two separate outlets eachassociated with a distinct flow channel; iii. a third valve componentinterposed between the first and second components associated with thedistinct flow channels for controlling flow through the distinct flowchannels; B. said first, second and third components forming saidhousing (a) with the components establishing the at least two mutuallydistinct flow channels through the housing, and (b) the mutuallydistinct flow channels being sealed one from the other; C. whereby eachsaid first projection can be connected to a terminal complementary partof a two-part connector such that when the connector is complete fluidcan flow through the at least two distinct flow channels under thecontrol of the valve component; and D. whereby the separate outlets ofthe second component can be connected to separate lumens each terminatedwith its own connection element for fluid flow relative to a patient.14. The invention of claim 13 wherein the housing includes a reservoirand a fluid channel for introducing fluid to said reservoir, and aplurality of passageways placing said reservoir in fluid communicationwith said plurality of separate outlets.
 15. The invention of claim 14wherein check valves are interposed in the plurality of passageways. 16.The invention of claim 13 wherein the third valve component is incommunication with the plurality of passageways for controlling fluidflow in each distinct flow channel by priming said channel, flushingsaid channel, shutting off said channel, and enabling flow through saidchannel.
 17. The invention of claim 13 wherein two fittings aremountable on adjacent first projections, one for enabling flow throughthe distinct flow channels associated with both adjacent firstprojections, and one for shutting off flow through the distinct flowchannels associated with both adjacent first projections and protectingagainst contamination.
 18. A method for manufacturing a housing forsupporting proximal inlet ports of a plurality of isolated flowchannels, for use in a patient fluid administration system, wherein eachof said flow channel further comprises a distal outlet for connecting toa patient fluid administration member comprising the steps of: a.providing a first component comprised of a first member having aplurality of spaced first openings each associated with a distinct flowchannel and a plurality of spaced upward, tubular first projectionssurrounding and aligned with said first openings and open at their upperand lower extremities each associated with a distinct flow channel, saidfirst projections formed as one part of a two-part connector; b.providing a second component comprised of a second member having aplurality of spaced second openings each associated with a distinct flowchannel and defining a plurality of longitudinally spaced separateoutlets each associated with a distinct flow channel; c. providing anintermediate component comprised of a third member being resilient andhaving a plurality of spaced third openings each associated with adistinct flow channel and a plurality of spaced upward annular secondprojections each associated with a distinct flow channel, each secondprojection surrounding a respective third opening, said projectionshaving closures at their upper extremities with normally closed slitsdefined in said closures and being open at their lower extremities; d.arranging said first, second and third components together with theintermediate component between the first and second components andintegrated together to form said housing; e. positioning said secondprojections in the first projections with the closures at the upperextremities of the second projections exposed at the upper extremitiesof the first projections; f. placing the second openings and the thirdopenings in fluid communication; g. establishing the integratedcomponents as a plurality of mutually distinct flow channels through thehousing; h. sealing the mutually distinct flow channels one from theother by the intermediate component; i. whereby each said firstprojection can be connected to a fluid administration set via a terminalcomplementary part to said one part of the two-part connector such thatwhen the connector is complete, the resilient second projection receivedin said first projection is depressed downwardly forcing the normallyclosed slit defined in the closure at the upper extremity thereof toopen; and j. whereby the separate outlets of the second component can beconnected to separate lumens each terminated with its own element forinfusing fluid into a patient.
 19. The method of claim 18 including thefurther step of mounting a plurality of valves in the housing upstreamof the plurality of spaced separate outlets for controlling fluid flowthrough the plurality of mutually distinct flow channels, andassociating each said valve with a distinct flow channel.
 20. The methodof claim 19 including the further steps of defining in the secondcomponent a groove extending laterally offset from the plurality ofspaced second openings, and defining in said second componentpassageways extending from said groove to said valves for controllingfluid flow in each distinct flow channel by priming said channel,flushing said channel, shutting off said channel, and enabling flowthrough said channel.